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2013 FDA Drug Approval Calendar


BOSTON ( TheStreet) -- Gilead Sciences (GILD) and Amarin (AMRN) highlight the updated list of biotech and pharmaceutical companies with FDA drug approval decisions expected for the remainder of 2013.

The next era of hepatitis C therapy could begin on Dec. 6, if FDA approves Gilead's sofosbuvir. Amarin is hoping FDA approves an expanded label for its prescription-grade fish oil pill Vascepa on Dec. 20.

Sarepta Therapeutics (SRPT) and Pharmacyclics (PCYC) aren't on the list but are still very much in the investor spotlight. Sarepta and FDA are still going back and forth over the the company's request to file an accelerated approval application for eteplirsen to treat Duchenne muscular dystrophy. We may have some resolution early in the third quarter.

Pharmacylics and partner Johnson & Johnson (JNJ) are expected to seek FDA approval for their blood-cancer drug ibrutinib before the end of the third quarter. FDA has already annointed ibrutinib with multiple breakthrough therapy designations, so it makes sense for the agency to approve the drug quickly. Is an ibrutinib approval before year end a possibility? I think so, in fact, I'd say the Street expects an early approval.

Let's not forget the importance of European drug approvals. Here are the dates for the remaining Committee for Medicinal Products for Human Use (CHMP) meetings in 2013:

May 27-30; June 24-27; July 22-25; Aug. 19-22; Sept. 16-19; Oct. 21-24; Nov. 18-2; and Dec. 16-19.

The most closely watched, upcoming European drug approval decisions include Dendreon (DNDN) (Provenge, prostate cancer); Aegerion Pharmaceuticals (AEGR) (Juxtapid, homozygous familial hypercholesterolemia) and Celgene (CELG) (Pomalyst, multiple myeloma.)

Biotech and drug stocks below are listed in chronological order based on the closest regulatory catalyst -- FDA drug approval decisions and advisory panels.

Merck (MRK)
Drug/indication: Suvorexant for insomnia
FDA advisory panel: May 22
Approval decision date: June-July

Valeant Pharmaceuticals (VRX)
Drug/indication: Efinaconazole, toe-nail fungus
Approval decision date: May 23

Depomed (DEPO)
Drug/indication: Sefelsa, menopause
Approval decision date: May 31

Zogenix (ZGNX)
Drug/indication: Zohydro, chronic pain
Approval decision date: Summer

GlaxoSmithKline (GSK)
Drug/indication: Dabrafenib, melanoma
Approval decision date: June 3

Aveo Pharmaceuticals (AVEO)
Drug/indication: Tivozanib, kidney cancer
Approval decision date: July 26

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